The present invention, in some embodiments thereof, relates to the field of medical care for surgically created openings (stoma) in living subjects, and more particularly, to devices and methods for covering a stoma as may be used in the case of a colostomy, ileostomy or urostomy.
In ostomy surgeries, an end or a side of a healthy portion of intestine is surgically attached to a stoma formed in the abdominal wall. Attachment may be to the visceral side, or a surgeon may pass the intestinal portion through the stoma and attach it to the outside of the abdominal wall. Large or small intestine is attached, depending on the type of ostomy.
A stoma may be permanently left in a patient when intestinal content can no longer pass out through the anus, due, for example, to colon cancer, diverticulitis, trauma, or inflammatory bowel disease. A stoma may be temporary, for example, following an operation on a section of bowel requiring a healing period.
Use of an ostomy appliance is indicated for patients with a stoma, to help manage stomal discharge. According to the nature of the stoma, stomal discharge comprises, for example, fecal matter, urine, and/or mucus. Appliances may be wholly external, or at least partially internal. Common elements of ostomy appliances include a pouch for collecting stomal discharge, and a means to seal the pouch over the stoma. In some cases, a plug or cover is used in addition to, or in place of a pouch.
Described ostomy appliance designs include the following:
U.S. Pat. No. 8,070,737 relates to “a controlled evacuation ostomy appliance compris[ing] a membrane that is urged into sealing engagement with a stoma, by the generation of radial tension in the membrane. A tensioning device applies tension, with respect to the stoma, at one or more positions that are (i) outboard of the periphery of the projecting portion of the stoma, and/or (ii) between the level of the peristomal skin and the level of the most projecting part of the stoma. Tension limiting means are disclosed. The membrane may be gas-permeable to allow flatus to be vented”.
U.S. Pat. No. 8,092,437 relates to “a flexible membrane [ . . . ] situated within a rigid or semi-rigid cap. The edge of the cap wall is adhesively fixed to the tissue surrounding the stoma. The interior of the cap is pressurized to press the membrane to seal the stoma against the discharge of solid and semi-solid waste. Gas escapes through a vent with a filter element. The cap can be pressurized by an external pump or an integral pump member situated on top of the cap. A relief valve prevents over pressurization. A collection pouch can be provided as part of a device. The device can be removably mounted on a standard two-piece faceplate”.
U.S. Pat. No. 7,250,040 relates to “an arrangement at a stoma bag of the type used by persons or animals with a colostoma, including a flexible bag (flexibag) and a ring fastener/magazine ring, where the ring fastener/magazine ring is designed to be connected to a stoma plate, and where, in its initial position, the entire flexibag is located in or in close proximity to the ring fastener/magazine ring”.